The NDOHD system is intended for viewing, acquiring, archiving and retrieving video and still images of endoscopic and fluoroscopic procedures. The professionals or practitioners using this system would be medical doctors or clinicians such as speech pathologists. The device is a prescription device. The NDOHD system is not intended to be used in an environment that requires sterilization.

Device Description

The NDOHD High Definition Imaging System (NDOHD) was initially commercialized in 2011 as a photographic accessory for endoscopes (FEM), Class I Exempt device. Altaravision has expanded the capabilities of the NDOHD system to include a computer and a camera, included a lossy image compression mechanism using standard irreversible compression technique, H.264, added a time code on the display of the image, created camera controls and added profiles for multiple camera settings and user preferences. Therefore, Altaravision has created a picture archiving and communication system that provides capabilities related to the acceptance, transfer, display, storage and digital processing of images and videos.

AI/ML Overview

Here's an analysis of the provided 510(k) summary regarding the Altaravision NDOHD High Definition Imaging System, structured according to your requested points:

This device is a Picture Archiving and Communications System (PACS) and underwent a 510(k) submission, classifying it as a Class II medical device. The 510(k) submission primarily focuses on demonstrating substantial equivalence to a predicate device rather than conducting a separate clinical study to prove novel performance against specific acceptance criteria.

Therefore, there is no explicit table of acceptance criteria and reported device performance in the same manner one would expect for a diagnostic AI device or a device requiring new efficacy claims. The "acceptance criteria" for a 510(k) of this nature are implicitly met by demonstrating substantial equivalence through technical and functional comparisons, and adherence to relevant standards.

1. Table of Acceptance Criteria and Reported Device Performance

As noted, this 510(k) is for a PACS device demonstrating substantial equivalence, not a new AI diagnostic device with specific performance metrics like sensitivity or specificity. Thus, a traditional table of "acceptance criteria" and "reported device performance" in terms of clinical accuracy is not provided in the document.

Instead, the "acceptance criteria" are implied by conformance to international and FDA standards, and the "reported performance" is essentially the device's functional capabilities compared to a predicate device.

Category	Acceptance Criteria (Implied by 510(k) Process)	Reported Device Performance (as demonstrated by substantial equivalence to K991738 and adherence to standards)
Intended Use	Must be the same or very similar to the predicate device.	The NDOHD system's intended use (`viewing, acquiring, archiving and retrieving video and still images of endoscopic and fluoroscopic procedures`) is determined to be the Same as predicate.
Indications for Use	Must be the same or very similar to the predicate device.	The NDOHD system's indications for use are determined to be the Same as predicate.
Target Population	Must be the same or very similar to the predicate device.	Target population (`Medical doctors or clinicians such as speech pathologists`) is determined to be the Same as predicate.
Display	Must be functionally comparable or superior, suitable for the intended use.	Uses a built-in computer display, which is considered Similar to predicate (NEC MultiSync E900+).
Storage Medium	Must be suitable for archiving and retrieving images.	Uses a non-removable hard drive, considered Similar to predicate (removable 2Gb hard drive). Functionally comparable.
Video Output Format	Must be suitable for image processing and archiving.	Uses `.mov H.264 Video` and `.tiff still images`. Considered Similar to predicate (MJPEG and AVI), with the NDOHD using an OS agnostic format compared to the predicate's Windows-specific formats.
Camera CCD	If integrated, must provide adequate image quality for the intended use.	1032x762 CCD, 1/3" sensor, 31 FPS, 800Mb/s. The predicate device listed "Optional" for Camera. The NDOHD's integrated camera is compared to an optional component of the predicate.
Lossy Image Compression	Must utilize a known and accepted compression technique.	Uses H.264 compression. Considered Similar to predicate ("Yes," exact type unknown for predicate).
Energy	Must comply with safety standards for medical electrical equipment.	Computer built-in battery operated. Considered Similar to predicate (UPS battery operated). Both use battery during operation, and NDOHD includes safety controls to prevent use while plugged into AC power.
Software Functionality	Must adequately control recording, playback, storage, and retrieval of medical images.	NDOHD Software controls recording, playback, storage, retrieval, and live view of HD video, audio, and images. Considered Similar to predicate (DVRS Software controlling recording, playback, storage, retrieval of digital video and audio). NDOHD offers live view and is Macintosh-compatible, while the predicate is Microsoft-compatible.
Software Validation	Must comply with FDA guidance for medical device software.	Validation completed according to "General Principles of Software Validation; Final Guidance for Industry and FDA Staff, January 11, 2002" and "Guidance for the Submission of Premarket Notifications for Medical Image Management Devices, July 27, 2000".
Electrical Safety	Must comply with relevant IEC standards for medical electrical equipment.	Testing completed according to IEC 60601-1, IEC 60601-1-1, and IEC 60601-2-18.

2. Sample Size Used for the Test Set and the Data Provenance

This document does not describe a clinical study with a "test set" of patient data in the typical sense (e.g., a set of medical images for diagnostic performance evaluation). The testing described relates to software validation and electrical safety, which are engineering and quality assurance activities, not clinical performance studies using patient data.

Sample Size for Test Set: Not applicable/not specified for clinical performance. The testing involved functional and safety assessments of the device itself.
Data Provenance: Not applicable, as no external patient data test set was used for performance claims.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable. No ground truth establishment by experts for a test set of patient data is mentioned because this is a PACS device whose 510(k) focused on substantial equivalence through functional and safety testing, not diagnostic performance.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

Not applicable. No patient data test set requiring expert adjudication was described.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a PACS for viewing, acquiring, archiving, and retrieving images. It is not an AI-assisted diagnostic tool, and therefore, an MRMC study comparing human reader performance with and without AI assistance was not conducted or mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. The NDOHD system is a human-in-the-loop system (a PACS) for medical professionals. It does not contain a standalone AI algorithm for diagnostic interpretation in the way one might evaluate AI performance for, say, lesion detection.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable. For the software validation and electrical safety tests, the "ground truth" would be the specifications, requirements, and industry standards themselves, rather than clinical ground truth from patient data.

8. The Sample Size for the Training Set

Not applicable. This document is for a medical device (PACS) that does not describe an AI algorithm explicitly trained on a dataset for clinical performance.

9. How the Ground Truth for the Training Set was Established

Not applicable, as no AI training set is described.

Summary

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510(k) Summary

Altaravision K131873

This 510(k) Summary is in conformance with 21CFR 807.92

Submitter:

Altaravision, Inc. 130 Salem Towne Court Apex, NC 27502 t

Primary Contact:

Rita King MethodSense, Inc. Email: ritaking@methodsense.com Phone: 919-313-3961 Fax: 919-313-3979

Company Contact:

Stuart Bradley Chief Executive Officer

SEP 2 5 2013

Date Prepared: June 18, 2013

Device Name and Classification

Trade Name:	NDŎHD High Definition Imaging System (NDŎHD)
Common Name:	Picture Archiving Communications System (PACS)
Classification:	Class II
Regulation Number:	892.2050 – Picture Archiving and Communications System(PACS)
Classification Panel:	Radiology
Product Code:	LLZ

Predicate Device

Trade Name:	Digital Video Recording System
Common Name:	System, Image Processing
510(k) Submitter / Holder:	Kay Elemetrics Corp.
510(k) Number:	K991738
Regulation Number:	892.2050 – Picture Archiving and Communications System(PACS)
Classification Panel:	Radiology
Product Code:	LLZ

NDOHD High Definition Imaging System Traditional 510(k)

Confidential

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Device Description and Intended Use

The NDOHD system is intended for viewing, acquiring, archiving and retrieving video and still images of endoscopic and fluoroscopic procedures.

Indications for Use

Substantial Equivalence:

The NDOHD system is substantially similar to a predicate device currently on the market. This device is:

Digital Video Recording System (DVRS) K991738 .
Both devices use very similar technologies, overall design and operating principals.

The primary differences in the technology between the NDOHD System and the DVRS are described in the table below:

Item	Subject Device	Predicate Device	Comparison
	NDOHD High DefinitionImaging System (NDOHD)	Digital VideoRecording System(DVRS)
Intended Use	The NDOHD system isintended for viewing,acquiring, recording,archiving and retrieving videoand still images ofendoscopic and fluoroscopic	The intended use ofthe DVRS is forviewing, acquiring,recording, archivingand retrieving videoimages of	Same aspredicate
Item	Subject Device	Predicate Device	Comparison
	NDOHD High DefinitionImaging System (NDOHD)	Digital VideoRecording System(DVRS)
	procedures.	endoscopic andfluoroscopicprocedures
Indications forUse	The NDOHD system isintended for viewing,acquiring, recording,archiving and retrieving videoand still images ofendoscopic and fluoroscopicprocedures. Theprofessionals or practitionersusing this system would bemedical doctors or clinicianssuch as speech pathologists.The device is a prescriptiondevice. The NDOHD system isnot intended to be used in anenvironment that requiressterilization.	The intended use ofthe DVRS is forviewing, acquiring,recording, archivingand retrieving videoimages ofendoscopic andfluoroscopicprocedures. Theimages may bemonochrome orcolor. Theprofessionals orpractitioners usingthis system would bemedical doctors orclinicians such asspeech pathologists.The device is a -prescription device.	Same aspredicate
Target Population	Medical doctors or clinicianssuch as speech pathologists	Medical doctors orclinicians such asspeech pathologists	Same aspredicate
Display	Built-in computer display	NEC MultiSyncE900+	Similar topredicate
Storage Medium	Non removable hard drive	Removable 2Gb harddrive	Similar topredicate
Video OutputFormat	.mov H.264 Video and .tiff stillimages	MJPEG and AVI	Similar topredicate.Predicate usesWindowsspecificformats, whilethe NDOHDsystem isusing an OSagnosticformat.
Camera CCD(chargedischarge)	1032x762 CCD. 1/3" sensor,31 FPS (Frames per second)progressive scan, 800Mb/s,bit depth: 8-14 bit.	Optional	The use of acamera isoptional for thepredicate
Item	Subject Device	Predicate Device	Comparison
NDOHD High DefinitionImaging System (NDOHD)	Digital VideoRecording System(DVRS)
Lossy ImageCompression	Yes, H.264 compression	Yes	Similar topredicate. Theexactcompressiontype of thepredicate isunknown
Energy	Computer built in batteryoperated	UPS battery operated	Similar topredicate. Bothsystems usebattery duringoperation. TheNDOHD systemprovides safetycontrols topreventoperators fromusing thedevice whileplugged into anAC poweroutlet.
Software	NDOHD Software used tocontrol the recording,playback, storage, retrieval,and live view of high definitionvideo (.mov), audio andimages (.tiff) data.	DVRS Software usedto control therecording, playback,storage and retrievalof digital video(MJPEG images) andaudio data.	Similar topredicate. TheNDOHDSoftwareprovides a liveview of theprocedure inprogress.NDOHDSoftware isdevelopedusingMacintosh-compatibletechnology.DVRS isdevelopedusingMicrosoft-compatibletechnology.

Detailed Comparison of the Subject and Predicate Devices

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NDOHD High Definition Imaging System Traditional 510(k)

Confidential

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・・・

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Testing

Software Validation and Electrical Safety Testing have been completed according to FDA Guidance documents and Industry Standards as follows:

General Principles of Software Validation; Final Guidance for Industry and FDA Staff, . January 11, 2002
Guidance for the Submission of Premarket Notifications for Medical Image . Management Devices, July 27, 2000
. IEC 60601-1: 1998+A1:1991+A2:1995+ Am.11+ Am.12 + Am.13:1996, Medical Electrical Equipment Part 1-2: General Requirements for Safety
. IEC 60601-1-1, Ed 2.0, Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical . electrical systems
. IEC 60601-2-18: 2009, Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment

Laboratory data is not required. The NDOHD system utilizes standard irreversible compression techniques (H.264).

Substantial Equivalence Conclusions

In conclusion, the intended use for the NDOHD system is the same as that of the predicate device, the technological characteristics demonstrate that the NDOnp system is equivalent to the predicate device, and the testing shows that the NDOHD system is substantially equivalent to the predicate device and assures that the NDÔно system is as safe and effective as the predicate devices. ·

Conclusion

The 510(k) Pre-market Notification for the NDOHD system contains adequate information and data to determine that the NDÔHD system is as safe and effective as the legally marketed predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 25, 2013

Altaravision Incorporated % Ms. Rita King CEO PO Box 110352 Durham, North Carolina 27709

Re: K131873

Trade/Device Name: NDOHD High Definition Imaging System (NDOHD) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: June 18, 2013 Received: June 27, 2013

Dear Ms. King:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register,

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Rita King

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/McdicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industrv/default.htm.

Sincerely yours,

Long H. ...... Chen -A

For

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

Indications for Use Statement

510(k) Number (if known): K131873

Device Name: NDOHD High Definition Imaging System (NDOHD)

Indications for Use

The NDÔно system is intended for viewing, acquiring, archiving and retrieving video and still images of endoscopic and fluoroscopic procedures. The professionals or practitioners using this system would be medical doctors or clinicians such as speech pathologists. The device is a prescription device. The NDOнь system is not intended to be used in an environment that requires sterilization.

Prescription Use Yes	AND/OR	Over-The-Counter Use No
(Part 21 CFR 801 Subpart D)		(Part 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation

Neil R Ogder 2013.09.25 10:04:3 3-04'00'

(Division Sign-Off) for MXM

Division of Surgical Devices

510(k) Number ________________________________________________________________________________________________________________________________________________________________

NDOHD High Definition Imaging System Traditional 510(k) Page 5-1 of 5-1

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).